Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorFondazione Italiana Linfomi - ETS

About this trial

This is a prospective, phase 2, multicenter, open-label, single-arm study. Primary objective is to assess the efficacy of loncastuximab tesirine given as consolidation therapy after salvage immunochemotherapy in BTKi (Bruton Tyrosine Kinase inhibitors) -treated (or BTKi intolerant) R/R (Relapse or Refractory) MCL (Mantle Cell Lymphoma) patients. The sponsor of this clinical trial is Fondazione Italiana Linfomi - ETS (FIL ETS).

Eligibility criteria

Qualifiers

Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification

Age ≥ 18 and < 85 years

Relapsed/Refractory disease after one, two, three or four lines of treatment

Bendamustine-naive or relapsed after at least one year after the last cycle of a bendamustine-containing regimen

Disqualifiers

Subjects who have received a bendamustine containing regimen and relapsed less than one year after the end of treatment.

Known history of hypersensitivity to human antibodies.

Allogenic stem cell transplant within 6 months prior to start of first study drug.

Allogenic stem cell transplant with active / uncontrolled graft-versus-host disease.

Trial design

Treatments tested in this trial

  • Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C))
  • Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at reduced dose (R-BAC, Rituximab - Bendamustine, Ara-C)

Treatment groups

49 Participants
are divided into 1 treatment group